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Effects of Epigallocatechin Gallate (EGCG) in Healthy, Young Adults

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ClinicalTrials.gov Identifier: NCT00981292
Recruitment Status : Completed
First Posted : September 22, 2009
Results First Posted : April 13, 2012
Last Update Posted : April 13, 2012
Sponsor:
Information provided by (Responsible Party):
Crystal Haskell, Northumbria University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Basic Science
Conditions Cognitive Function
Mood
Interventions Dietary Supplement: EGCG
Dietary Supplement: Placebo
Enrollment 32
Recruitment Details  
Pre-assignment Details  
Arm/Group Title 135mg EGCG Then 0mg EGCG Then 270mg EGCG 270mg EGCG Then 135mg EGCG Then 0mg EGCG 0mg EGCG Then 135mg EGCG Then 270mg EGCG 135mg EGCG Then 270mg EGCG Then 0mg EGCG 0mg EGCG Then 270mg EGCG Then 135mg EGCG 270mg EGCG Then 0mg EGCG Then 135mg EGCG
Hide Arm/Group Description Those participants who received treatment in this order. Those participants who received treatment in this order. Those participants who received treatment in this order. Those participants who received treatment in this order. Those participants who received treatment in this order. Those participants who received treatment in this order.
Period Title: Day 1
Started 7 4 6 4 4 7
Completed 6 4 6 4 4 5
Not Completed 1 0 0 0 0 2
Reason Not Completed
Protocol Violation             1             0             0             0             0             2
Period Title: Day 2
Started 6 4 6 4 4 5
Completed 4 4 6 4 4 5
Not Completed 2 0 0 0 0 0
Reason Not Completed
Protocol Violation             2             0             0             0             0             0
Period Title: Day 3
Started 4 4 6 4 4 5
Completed 4 4 6 4 4 4
Not Completed 0 0 0 0 0 1
Reason Not Completed
Protocol Violation             0             0             0             0             0             1
Arm/Group Title 135mg EGCG Then 0mg EGCG Then 270mg EGCG 270mg EGCG Then 135mg EGCG Then 0mg EGCG 0mg EGCG Then 135mg EGCG Then 270mg EGCG 135mg EGCG Then 270mg EGCG Then 0mg EGCG 0mg EGCG Then 270mg EGCG Then 135mg EGCG 270mg EGCG Then 0mg EGCG Then 135mg EGCG Total
Hide Arm/Group Description Those participants who received treatment in this order. Those participants who received treatment in this order. Those participants who received treatment in this order. Those participants who received treatment in this order. Those participants who received treatment in this order. Those participants who received treatment in this order. Total of all reporting groups
Overall Number of Baseline Participants 7 4 6 4 4 7 32
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 4 participants 6 participants 4 participants 4 participants 7 participants 32 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
7
 100.0%
4
 100.0%
6
 100.0%
4
 100.0%
4
 100.0%
7
 100.0%
32
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 7 participants 4 participants 6 participants 4 participants 4 participants 7 participants 32 participants
22  (4) 22  (4) 22  (4) 22  (4) 22  (4) 22  (4) 22  (4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 4 participants 6 participants 4 participants 4 participants 7 participants 32 participants
Female
4
  57.1%
3
  75.0%
3
  50.0%
3
  75.0%
3
  75.0%
2
  28.6%
18
  56.3%
Male
3
  42.9%
1
  25.0%
3
  50.0%
1
  25.0%
1
  25.0%
5
  71.4%
14
  43.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United Kingdom Number Analyzed 7 participants 4 participants 6 participants 4 participants 4 participants 7 participants 32 participants
7 4 6 4 4 7 32
1.Primary Outcome
Title Modulation of Levels of Total Haemoglobin
Hide Description This measure assessed changes in levels of total haemoglobin during the 42 minute post- dose task period. Levels are in μmol/L and represent change from baseline levels.
Time Frame 42 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
If NIRS readings were deemed not too affected by artefacts (usually caused by participants moving the headband in some way) then they were utilized in the analysis.
Arm/Group Title 135mg EGCG 270mg EGCG Placebo
Hide Arm/Group Description:
All participants when consumed 135mg EGCG.
All participants when consumed 270mg EGCG.
All participants when consumed Placebo.
Overall Number of Participants Analyzed 27 27 27
Mean (Standard Error)
Unit of Measure: μmol/L
-1.4  (0.5) -1.3  (0.3) -1.7  (0.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 135mg EGCG
Comments This data was analysed by two-way repeated measures ANOVA (task [epoch] x treatment). In the case of those analyses that showed a significant main effect of treatment or a task/epoch x treatment interaction, planned comparisons of data from each task or epoch were then made between placebo and each of the EGCG treatment groups using t tests calculated with the Mean Squares Error from the ANOVA.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments A Bonferroni adjustment was made for multiplicity.
Method ANOVA
Comments [Not Specified]
2.Secondary Outcome
Title Number of Participants With Significant Modulation of Cognitive Performance
Hide Description The cognitive performance of participants was assessed via a range of computerised, mentally demanding, executive function tasks: Serial 3s and 7s subtractions, oddball reaction time task, rapid visual information processing, stroop and simple reaction time.These tasks were completed at baseline and then again 45 minutes after treatment administration. Significant modulation was determined if participants' post dose scores were significantly higher than baseline.
Time Frame 42 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
If participants were deemed to have completed the tasks to the best of their ability then their scores were utilized in the analysis.
Arm/Group Title 135mg 270mg EGCG Placebo
Hide Arm/Group Description:
All participants when consumed 135mg EGCG.
All participants when consumed 270mg EGCG.
All participants when consumed Placebo.
Overall Number of Participants Analyzed 27 27 27
Measure Type: Number
Unit of Measure: Participants
0 0 0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 135mg, 270mg EGCG, Placebo
Comments Task performance data were analysed by within subjects ANCOVA (treatment) with pre-treatment performance included as a co-variate for each individual task/measure.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
3.Secondary Outcome
Title Number of Participants With Significant Modulation of Mood.
Hide Description Mood was assessed via computerised visual analogue scales at baseline and post- dose time points. Mood scores were calculated as change from baseline. And significant modulation was determined if baseline scores were significantly different to post dose.
Time Frame 42 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
As long as data for all participants was captured for all 3 sessions then that participants data was utilized in the analysis.
Arm/Group Title 135mg EGCG 270mg EGCG Placebo
Hide Arm/Group Description:
All participants when consumed 135mg EGCG.
All participants when consumed 270mg EGCG.
All participants when consumed Placebo.
Overall Number of Participants Analyzed 27 27 27
Measure Type: Number
Unit of Measure: Participants
0 0 0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 135mg EGCG, 270mg EGCG, Placebo
Comments Mood data was analysed via student t-test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 135mg EGCG Then 0mg EGCG Then 270mg EGCG 270mg EGCG Then 135mg EGCG Then 0mg EGCG 0mg EGCG Then 135mg EGCG Then 270mg EGCG 135mg EGCG Then 270mg EGCG Then 0mg EGCG 0mg EGCG Then 270mg EGCG Then 135mg EGCG 270mg EGCG Then 0mg EGCG Then 135mg EGCG
Hide Arm/Group Description Those participants who received treatment in this order. Those participants who received treatment in this order. Those participants who received treatment in this order. Those participants who received treatment in this order. Those participants who received treatment in this order. Those participants who received treatment in this order.
All-Cause Mortality
135mg EGCG Then 0mg EGCG Then 270mg EGCG 270mg EGCG Then 135mg EGCG Then 0mg EGCG 0mg EGCG Then 135mg EGCG Then 270mg EGCG 135mg EGCG Then 270mg EGCG Then 0mg EGCG 0mg EGCG Then 270mg EGCG Then 135mg EGCG 270mg EGCG Then 0mg EGCG Then 135mg EGCG
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
135mg EGCG Then 0mg EGCG Then 270mg EGCG 270mg EGCG Then 135mg EGCG Then 0mg EGCG 0mg EGCG Then 135mg EGCG Then 270mg EGCG 135mg EGCG Then 270mg EGCG Then 0mg EGCG 0mg EGCG Then 270mg EGCG Then 135mg EGCG 270mg EGCG Then 0mg EGCG Then 135mg EGCG
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/7 (0.00%)   0/4 (0.00%)   0/6 (0.00%)   0/4 (0.00%)   0/4 (0.00%)   0/7 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
135mg EGCG Then 0mg EGCG Then 270mg EGCG 270mg EGCG Then 135mg EGCG Then 0mg EGCG 0mg EGCG Then 135mg EGCG Then 270mg EGCG 135mg EGCG Then 270mg EGCG Then 0mg EGCG 0mg EGCG Then 270mg EGCG Then 135mg EGCG 270mg EGCG Then 0mg EGCG Then 135mg EGCG
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/7 (0.00%)   0/4 (0.00%)   0/6 (0.00%)   0/4 (0.00%)   0/4 (0.00%)   0/7 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Emma Wightman
Organization: Northumbria university
Phone: +44 (0) 191 2437253
Responsible Party: Crystal Haskell, Northumbria University
ClinicalTrials.gov Identifier: NCT00981292     History of Changes
Other Study ID Numbers: 24Z1
First Submitted: September 21, 2009
First Posted: September 22, 2009
Results First Submitted: June 25, 2010
Results First Posted: April 13, 2012
Last Update Posted: April 13, 2012